Roche initiates phase III clinical trial of Actemra/RoActemra plus remdesivir in hospitalised patients with severe COVID-19 pneumonia
Basel, 28 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the initiation of a global phase III, randomised, double-blind, multicentre study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalised patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc.   (Source: Roche Media News)
Source: Roche Media News - May 28, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s Port Delivery System with ranibizumab shows positive phase III results in neovascular age-related macular degeneration
Basel, 27 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from the phase III Archway study, evaluating Port Delivery System with ranibizumab (PDS) in people living with neovascular or “wet” age-related macular degeneration (nAMD). PDS is a permanent refillable eye implant, approximately the size of a grain of rice, which continuously delivers a customised formulation of ranibizumab over a period of months. The Archway trial met its primary endpoint, demonstrating that patient s with PDS who received refills every six months achieved visual acuity outcomes equivalent to those recei...
Source: Roche Media News - May 27, 2020 Category: Pharmaceuticals Source Type: news

Roche acquires Stratos Genomics to further develop DNA based sequencing for diagnostic use
Basel, 22 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has acquired Stratos Genomics, an early-stage sequencing technology company to advance the development of Roche ’s nanopore sequencer. The acquisition provides Roche access to Stratos Genomics unique chemistry, Sequencing by Expansion (SBX™). The Roche nanopore sequencer, once developed, will utilise a novel approach that combines electronic and biological components to sequence DNA for fast, flexible and cost-effective clinical diagnostic testing.“Roche is dedicated to creating innovative diagnostics for the most challenging clinical con...
Source: Roche Media News - May 22, 2020 Category: Pharmaceuticals Source Type: news

New longer-term data reinforce safety of Roche ’s satralizumab in adults and adolescents with neuromyelitis optica spectrum disorder
Basel, 22 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new pooled pivotal satralizumab safety results for the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system disorder. These data are being presented at the 6th Annual Meeting of the European Academy of Neurology (EAN) and show satralizumab was well-tolerated in a broad patient population – including adolescents, for whom there is no approved medicine. Satralizumab is an investigational humanised monoclonal antibody that targets the interleukin-6 (IL-6) receptor, believed to play a key role in the infla...
Source: Roche Media News - May 22, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Tecentriq as a first-line monotherapy for certain people with metastatic non-small cell lung cancer
Basel, 19 May 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression (PD-L1 stained ≥ 50% of tumour cells [TC ≥ 50%] or PD-L1 stained tumour-infiltrating [IC] covering ≥ 10% of the tumour area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations.“We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option ...
Source: Roche Media News - May 19, 2020 Category: Pharmaceuticals Source Type: news

Roche launches new blood gas digital solution designed to improve patient care
Basel, 15 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the CE mark availability of Roche v-TAC, a new digital diagnostic solution that allows clinicians to obtain results for arterial blood gas values from patients with respiratory or metabolic abnormalities via a simpler, less invasive venous puncture through the use of a digital algorithm. Blood gas analysis is typically used in hospital point of care (POC) settings, where quick and accurate results are needed. This includes emergency rooms, intensive care units and operating rooms. The analysis provides clinicians with information about a patient ’s p...
Source: Roche Media News - May 15, 2020 Category: Pharmaceuticals Source Type: news

Roche to present first clinical data on novel anti-TIGIT cancer immunotherapy tiragolumab at ASCO
Basel, 14 May 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the Phase II CITYSCAPE trial, the first randomised study evaluating the efficacy and safety of tiragolumab plus Tecentriq® (atezolizumab) compared with Tecentriq alone as an initial (first-line) treatment for people with P D-L1-positive metastatic non-small cell lung cancer (NSCLC). Tiragolumab is a novel cancer immunotherapy designed to bind to TIGIT, an immune checkpoint protein expressed on immune cells. Both TIGIT and PD-L1 play an important role in immune suppression, and blocking both pathways could enhance anti -tumour a...
Source: Roche Media News - May 14, 2020 Category: Pharmaceuticals Source Type: news

A formative figure in the company's history: Roche Honorary Chairman Fritz Gerber dies at the age of 91
Basel, 11 Mai 2020 - On May 10th 2020 Dr. h.c. Fritz Gerber died in his 92nd year. For more than two decades, he had shaped Roche ' s development into a leading global healthcare company in an exceptionally successful dual role as Group CEO (1978-1998) and Chairman of the Board (1978-2001). He remained closely associated with Roche throughout his life as Honorary Chairman. Starting at the end of the 1970s, Fritz Gerber led the company from a difficult situation to new success. Under his leadership, Roche ' s Group structures were fundamentally renewed and decentralized – ranging from focusing on the core businesses to mo...
Source: Roche Media News - May 11, 2020 Category: Pharmaceuticals Source Type: news

Changes to the Roche Enlarged Corporate Executive Committee
Roche today announced that Michael Varney (1958) Ph.D., and Head of Genentech Research and Early Development (gRED) since 2015, will retire from the company at the end of July. (Source: Roche Media News)
Source: Roche Media News - May 11, 2020 Category: Pharmaceuticals Source Type: news

New data at the ASCO20 Virtual Scientific Program reflects Roche ’s commitment to accelerating progress in cancer care
Basel, 7 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from clinical trials of 19 approved and investigational medicines across 21 cancer types, will be presented at the ASCO20 Virtual Scientific Program organised by the American Society of Clinical Oncology (ASCO), which will be held 29-31 May, 2020. A total of 120 abstracts that include a Roche medicine will be presented at this year ' s meeting." At ASCO, we will present new data from many investigational and approved medicines across our broad oncology portfolio, " said Levi Garraway, M.D., Ph.D., Roche ' s Chief Medical Officer and Head o...
Source: Roche Media News - May 7, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s COVID-19 antibody test receives FDA Emergency Use Authorization and is available in markets accepting the CE mark
Basel, 03 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA)1 for its new Elecsys ® Anti-SARS-CoV-2 antibody test. The test is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2. Roche has already started shipping the new antibody test to leading laboratories globally and will ramp up pr oduction capacity to high double-digit millions per month to serve healthcare systems in countries accepting the CE mark2 as well as the U....
Source: Roche Media News - May 3, 2020 Category: Pharmaceuticals Source Type: news

New 6-year data for Roche ’s OCREVUS (ocrelizumab) show earlier treatment initiation nearly halves risk of needing walking aid in relapsing multiple sclerosis
             Basel, 28 April 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new analyses of Phase III OPERA I and OPERA II studies, as well as the open-label extensions, showing that OCREVUS ® (ocrelizumab) treatment reduced the risk of disease and disability progression in RMS and PPMS. These new analyses add additional evidence to the benefit-risk profile of OCREVUS, including the impact of MS on people’s daily lives. The data were selected for the 72nd American Academy of Neurolog y (AAN) Annual Meeting and will be made available online via virtual presentation in the coming weeks (in lieu of ...
Source: Roche Media News - April 28, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s risdiplam shows significant improvement in survival and motor milestones in infants with Type 1 spinal muscular atrophy (SMA)
Basel, 28 April 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented 1-year data from FIREFISH Part 2, a pivotal global study evaluating risdiplam in infants aged 1 – 7 months old with symptomatic Type 1 spinal muscular atrophy (SMA). The study met its primary endpoint with 29% of infants (12/41; p<0.0001) sitting without support for five seconds by month 12, as assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III). No infants achieve this milestone in the natural history of Type 1 SMA. In addition, 18 (43.9%) infants were able to hold their head upright...
Source: Roche Media News - April 28, 2020 Category: Pharmaceuticals Source Type: news

First quarter with 2% growth in Swiss francs, 7% at constant exchange rates
Group sales increase 2% in Swiss francs and 7% at constant exchange rates, driven by new products, more than compensating for impact of competition from biosimilars Pharmaceuticals Division sales up 7%, led by Tecentriq, Hemlibra, Ocrevus and Perjeta Diagnostics Division sales grow 5%, with molecular testing as main contributor (Source: Roche Media News)
Source: Roche Media News - April 22, 2020 Category: Pharmaceuticals Source Type: news

Roche receives FDA approval for cobas HPV test for use on the cobas 6800/8800 Systems to identify women at risk for cervical cancer
             Basel, 21 April 2020 - Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced US Food and Drug Administration (FDA) approval for the cobas ® HPV test for use on the fully automated, high-throughput cobas® 6800/8800 Systems. The cobas® HPV test identifies women at risk for cervical cancer by detecting the presence of high-risk human papillomavirus (HPV) DNA in cervical samples. Persistent high-risk HPV infections can develop into pre cancerous lesions and, if left untreated, these lesions can progress to cervical cancer.“The approval of our HPV test for the cobas 6800 and 8800 Systems enables molec...
Source: Roche Media News - April 21, 2020 Category: Pharmaceuticals Source Type: news